Method for treatment of airway stricture or stenosis

Abstract

A method of treating a recurring airway stricture or stenosis in a body lumen includes inserting a scope and a drug-coated balloon catheter into a target site comprising the recurring airway stricture or stenosis in the body lumen. The method includes inflating the balloon to an inflation diameter such that the coating contacts an interior of the body lumen at the target site. The method includes deflating the balloon and withdrawing the scope and the balloon catheter from the target site.

1 . A method of treatment of a recurring airway stricture or stenosis in an airway body lumen, the method comprising:
 inserting a scope and a balloon catheter into a target site at the recurring airway stricture or stenosis in the airway body lumen, wherein the balloon catheter comprises
 an elongated balloon, and 
 a coating layer overlying an exterior surface of the balloon, wherein the coating layer comprises one or more additives and an initial drug load of a therapeutic agent chosen from paclitaxel, docetaxel, taxol, rapamycin, sirolimus, zotarolimus, everolimus, tacrolimus, an analogue thereof, and a combination thereof; 
   inflating the balloon to an inflation diameter such that the coating contacts an interior of the body lumen at the target site;   deflating the balloon; and   withdrawing the scope and the balloon catheter from the target site.   
     
     
         2 . The method of  claim 1 , wherein prior to inflation the coating on the drug coated balloon is hydrated and/or soaked to activate the coating. 
     
     
         3 . The method of  claim 2 , further comprising flushing the target site with a flushing composition comprising water and/or saline, and performing the hydrating and/or soaking of the coating in the flushing composition at the target site. 
     
     
         4 . The method of  claim 2 , further comprising performing the hydrating and/or soaking of the drug coating outside the body with a flushing composition comprising water and/or saline prior to inserting the drug coated balloon into the target site. 
     
     
         5 . The method of  claim 4 , wherein the method is free of flushing at the target site. 
     
     
         6 . The method of  claim 2 , wherein the hydrating and/or soaking is performed for 0.1 minutes to 5 minutes. 
     
     
         7 . The method of  claim 1 , further comprising damaging, dilating, and/or removing the stricture or stenosis at the target site in the body lumen prior to the insertion of the scope and balloon catheter into the target site. 
     
     
         8 . The method of  claim 7 , wherein the damaging, dilating, and/or removing comprises surgical removal, electrocautery, laser ablation, cryoablation, radiofrequency ablation, mechanical debulking, rigid bronchoscopy dilation, knife-cutting, direct vision internal stricturotomy, use of an uncoated balloon to dilate the stricture or stenosis, or a combination thereof. 
     
     
         9 . The method of  claim 1 , wherein the one or more additives comprise:
 one or more water insoluble additives,   one or more slightly water insoluble and/or partially water insoluble additives,   one or more water soluble additives, or   a combination thereof.   
     
     
         10 . The method of  claim 1 , wherein the one or more additives are chosen from pentaerythritol ethoxylate, pentaerythritol propoxylate, pentaerythritol propoxylate/ethoxylate, N-acetylglucosamine, N-octyl-D-gluconamide, N-nonanoyl-N-methylglycamine, N-octanoyl-N-methyl glutamine, C6-ceramide, dihydro-C6-ceramide, cerabroside, sphingomyelin, galaclocerebrosides, lactocerebrosides, N-acetyl-D-sphingosine, N-hexanoyl-D-sphingosine, N-octonoyl-D-sphingosine, N-lauroyl-D-sphingosine, N-palmitoyl-D-sphingosine, sphingosine, polyethylene glycol (PEG) caprylic/capric diglycerides, PEG-8 caprylic/capric glycerides, PEG caprylate, PEG-8 caprylate, PEG caprate, PEG caproate, glyceryl monocaprylate, glyceryl monocaprate, glyceryl monocaproate, monolaurin, monocaprin, monocaprylin, monomyristin, monopalmitolein, monoolein, creatine, creatinine, agmatine, citrulline, guanidine, sucralose, aspartame, hypoxanthine, theobromine, theophylline, adenine, uracil, uridine, guanine, thymine, thymidine, xanthine, xanthosine, xanthosine monophosphate, caffeine, allantoin, (2-hydroxyethyl) urea, N,N′-bis(hydroxymethyl) urea, glycerol ethoxylate, glycerol propoxylate, trimethylolpropane ethoxylate, pentaerythritol, dipentaerythritol, crown ether, 18-crown-6,15-crown-5,12-crown-4, butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), a derivative thereof, and combinations thereof. 
     
     
         11 . The method of  claim 1 , wherein the one or more additives comprise pentaerythritol ethoxylate, pentaerythritol propoxylate, or a combination thereof. 
     
     
         12 . The method of  claim 1 , wherein the elongated balloon has a length of about 20 mm to about 300 mm, and wherein the balloon has a main diameter that is a nominal inflated diameter of 1 mm to 50 mm. 
     
     
         13 . The method of  claim 1 , wherein the balloon comprises at least one neck section on the balloon comprising a smaller diameter than a main diameter of the balloon when the balloon is inflated, the at least one neck section dividing the balloon into at least two main sections each having a diameter. 
     
     
         14 . The method of  claim 1 , wherein the initial drug load is from about 1 microgram to about 20 micrograms of the therapeutic agent per square millimeter of the balloon, measured when the balloon is at its nominal inflated diameter. 
     
     
         15 . The method of  claim 1 , wherein inserting the scope and the balloon catheter comprises:
 inserting the balloon catheter through a lumen of the scope, or   inserting the balloon catheter and the scope side-by-side.   
     
     
         16 . The method of  claim 1 , wherein the scope is an endoscope, rhinolaryngoscope, rhinoscope, bronchoscope, cystoscope, or a combination thereof. 
     
     
         17 . The method of  claim 1 , wherein the inflating is performed such that:
 the ratio of the inflation diameter to a normative body lumen diameter at the target site is about 1.0 to about 20,   the ratio of the inflation diameter to a normative body lumen diameter at the target site is about 1.0, 1.1, 1.2, or 1.31 to 10,   the balloon is inflated to a pressure that is equal to or greater than a nominal pressure of the balloon,   a stretch ratio of the inflated diameter of the balloon to a normative body lumen diameter at the target site is about 1.0 to about 20, or   a combination thereof.   
     
     
         18 . The method of  claim 1 , wherein the body lumen comprises a frontal sinus, ethmoid sinus, sphenoid sinus, maxillary sinus, nasal passage, supraglottis, glottis, subglottis, trachea, mainstem bronchus,  bronchus intermedius , and/or a lobar bronchus, and/or wherein the airway stricture or stenosis comprises a tracheal and/or bronchial stricture or stenosis. 
     
     
         19 . The method of  claim 1 , wherein the airway stricture or stenosis is a stricture or stenosis induced by repeated medication treatments, intubation, tracheostomy, tuberculosis infection, surgical removal, electrocautery, laser ablation, cryoablation, mechanical debulking, rigid bronchoscopic dilation, stent placement, balloon dilation, bronchial smooth muscle cells, eosinophils, IL-4, IL-5, IL-6, IL-13, IL-23, ILC2, mucus plug, goblet cells, fibrosis, cystic fibrosis, and/or one or more mucins. 
     
     
         20 . The method of claim, wherein
 the method is a method of treatment of laryngostenosis and/or subglottic stricture or stenosis, wherein the method further comprises damaging, dilating, and/or removing the laryngostenosis and/or subglottic stricture or stenosis at a target site in the body lumen; or   the method is a method of treatment of severe asthma, wherein the target site comprises a mainstem bronchus,  bronchus intermedius , and/or a lobar bronchus; or   the method is a method of treatment of, and/or a method of reduction of exacerbation of and/or hospitalization for, severe asthma, wherein the target site comprises a trachea, mainstem bronchus,  bronchus intermedius , and/or a lobar bronchus, wherein the method is free of flushing the target site, wherein the method comprises hydrating and/or soaking the coating outside the body to activate the coating; or   the method is a method of reducing a concentration of bronchial smooth muscle cells of a severe asthma patient, wherein the target site comprises bronchial smooth muscle cells in a body lumen; or   the method is a method of reducing a concentration of eosinophils, IL-4, IL-5, IL-6, IL-13, IL-23, and/or ILC2 in an airway tract, wherein the target site comprises a trachea, mainstem bronchus,  bronchus intermedius , and/or a lobar bronchus; or   the method is a method of treatment of a mucous plug in an airway, wherein the method further comprises removing mucous plug from a target site in a body lumen prior to inflation; or   the method is a method of reduction of concentration of goblet cells in an airway tract, wherein the target site comprises one or more goblet cells in a body lumen; or   the method is a method of reducing a concentration of one or more mucins in the airway tract, wherein the target site comprises a trachea, mainstem bronchus,  bronchus intermedius , and/or a lobar bronchus.